Multiple Myeloma Clinical Trial

Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Summary

This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.

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Full Description

PRIMARY OBJECTIVES:

I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).

II. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.

OUTLINE:

Participants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.

After completion of study treatment, participants were followed up to 1 week after completion of stem cell collection.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization
Ability to give informed consent
Glomerular filtration rate (GFR) > 30 ml/minute
Liver function tests < 2.5 x upper limit of normal (ULN)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less

Based on prior therapy patients will be classified into two categories:

Initial mobilizers with no exposure to alkylators
Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization

Exclusion Criteria:

Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy
Concomitant therapy with any drugs shown to have major interactions with desipramine
Concurrent use of drugs that are contraindicated with desipramine
Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) > 460 msec
Active alcohol abuse
Bipolar disorder
Untreated active major depression
History of seizures in the past 3 years
Pregnancy and lactation; refusal to use adequate contraception
Uncontrolled thyroid disease
GCSF or pegfilgrastim use within 14 days prior to enrollment
Bortezomib, Revlimid or thalidomide use within 7 days of enrollment
Patients with sickle cell disease

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

10

Study ID:

NCT01899326

Recruitment Status:

Terminated

Sponsor:

Albert Einstein College of Medicine

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There is 1 Location for this study

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Albert Einstein College of Medicine
Bronx New York, 10461, United States

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

10

Study ID:

NCT01899326

Recruitment Status:

Terminated

Sponsor:


Albert Einstein College of Medicine

How clear is this clinincal trial information?

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